About Cathy Oliveri

Cathy Oliveri spent 12 years at FDA, including 10 years at the Center for Devices and Radiological Health, which regulates medical devices in the United States. Her last role there was Assistant Director for Process Improvement, leading a team of 15 Lean Six Sigma practitioners on Center-wide projects spanning pre-market and post-market functions. Before that she worked in CDRH’s Office of In Vitro Diagnostics, the Office of the Commissioner, and the Office of Compliance.

Oliveri Consulting was founded in January 2026 to apply that regulatory experience, working directly with the companies being regulated.

Career History

FDA – Center for Devices and Radiological Health (2012 – 2025)

Twelve years at CDRH in progressively senior roles. As Assistant Director for Process Improvement, she led a 15-person team of Lean Six Sigma practitioners on Center-wide improvement projects, including accelerating Early Alerts for likely Class I recalls and building compliance dashboards. The team was the only FDA software group certified to ISO 9001:2015 and received two CDRH Awards.

Earlier CDRH roles included leading the agency’s first Office-level Digital Health Team, overseeing post-market data analytics for the Office of In Vitro Diagnostics, and reviewing cardiac device Establishment Inspection Reports, recalls, and 30 / 180 day PMAs in the Office of Compliance.

Transportation Security Administration (2008 – 2012)

Built TSA’s first Lean Six Sigma training and consulting program for the Office of Security Operations, growing it from $3M to $30M over three years across more than 130 airports.

Lockheed Martin Transportation and Security Solutions (LMTSS)

Senior Staff Systems Engineer and Certified Master Black Belt. Led Lean Six Sigma projects and contributed to LMTSS achieving Software Engineering Institute’s (SEI) Capability Maturity Model (CMMI) Level 5, the highest software maturity level achievable. Assessment at CMMI Level 5 provided a measurable competitive advantage on government contracts for mission critical systems such as Air Traffic Control.

Earlier Career

SAS Institute (1999–2001): Re-established the test department and trained staff on CMMI, ISO 9001, and FDA GMP’

IBM Corporation (1985 – 1999): Multiple roles from Software Developer to Advisory Software Engineer and Architect. Led the first ISO 9000 certification for any IBM Image product development group.

Education

MS, Computer Science – Johns Hopkins University, Whiting School of Engineering (GPA: 4.0)

BA, Statistics – Princeton University

Certifications